It was a busy week for the biotech sector with quite a few regulatory and other pipeline updates. While coronavirus-related news continues to grab headlines, other regulatory events were also in the spotlight. The most important news among these was biotech major Gilead GILD announcing an agreement to buy oncology company Immunomedics IMMU.
Recap of the Week’s Most Important Stories:
Gilead to Buy Immunomedics, Gets BTD for Oncology Drug: Gilead Sciences announced that it will acquire oncology company, Immunomedics, for $88 per share in cash or approximately $21 billion. The transaction is anticipated to close during the fourth quarter of 2020. The acquisition will add Trodelvy (sacituzumab govitecan-hziy), a first-in-class antibody-drug conjugate (ADC), to Gilead’s portfolio. Trodelvy was granted accelerated approval by the FDA in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support the full approval of Trodelvy in the United States in the fourth quarter of 2020. Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021. The acquisition will also broaden Gilead’s oncology portfolio/pipeline, which comprises Yescarta, Tecartus and magrolimab. The addition of Trodelvy will immediately accelerate Gilead’s sales.
Gilead announced that the FDA has granted Breakthrough Therapy designation to pipeline candidate, magrolimab, for the treatment of newly-diagnosed myelodysplastic syndrome (MDS). Magrolimab is a first-in-class, investigational anti-CD47 monoclonal antibody. MDS is a type of cancer caused by poorly formed or dysfunctional blood cells in the bone marrow. The candidate was added to Gilead’s pipeline through the acquisition of Forty Seven, Inc.
Regeneron’s Cocktail for Coronavirus Selected for RECOVERY Study: Regeneron Pharmaceuticals, Inc. REGN and the University of Oxford announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY) will evaluate the former’s investigational anti-viral antibody cocktail, REGN-COV2.
REGN-COV2 comprises two monoclonal antibodies (REGN10933 and REGN10987). RECOVERY is one of the world’s largest studies to find effective COVID-19 treatments. The trial is being coordinated by researchers at the University of Oxford, which acts as the sponsor for the research.
REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. The open-label phase III study will assess the impact of adding REGN-COV2 to the usual standard-of-care versus only standard-of-care. Both safety and efficacy of the candidate will be tested. Other endpoints include the impact on hospital stay and the need for ventilation. Approximately 2,000 patients will be randomly allocated to receive REGN-COV2 plus usual standard-of-care, and results will be compared with at least another 2,000 patients who will receive standard-of-care alone.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Seattle Genetics Up on Two New Oncology Deals With Merck: Shares of Seattle Genetics, Inc. SGEN gained after it announced that it has entered into two new strategic oncology collaborations with pharma giant, Merck. Per the agreement, the companies will co-develop and co-commercialize Seattle Genetics’ pipeline candidate, ladiratuzumab vedotin, which is an investigational antibody-drug conjugate (ADC) targeting LIV-1.
Additionally, Seattle Genetics granted Merck an exclusive license and rights to commercialize its oral tyrosine kinase inhibitor, Tukysa (tucatinib), for the treatment of HER2-positive cancers in Asia, the Middle East, Latin America and other regions outside the United States, Canada and Europe. Meanwhile, the company retains all commercial rights in the United States, Canada and Europe.
Vaxart Gets FDA Nod for Coronavirus Vaccine: Vaxart VXRT announced that the FDA has cleared its investigational new drug (IND) application to begin the phase I study on its oral coronavirus vaccine candidate. The company plans to initiate a phase I study on the same later this month.
The open-label, dose-ranging study will evaluate the oral COVID-19 vaccine candidate in healthy adults aged between 18 years and 55 years. The primary goal of the study is to investigate the safety and reactogenicity of two doses of the said vaccine. Secondary objectives include immunogenicity, duration of immune response and the occurrence of symptomatic COVID-19.
Marinus Surges on Positive Study Data: Shares of Marinus Pharmaceuticals, Inc. MRNS surged after it announced positive top-line results from its registrational phase III study evaluating the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD), which is a rare, genetic epilepsy with refractory seizures. The study results show that patients given ganaxolone showed a significant 32.2% median reduction in 28-day major motor seizure frequency compared to a 4% reduction for those receiving placebo, achieving the primary endpoint. Ganaxolone was generally well tolerated and the discontinuation rate in the active treatment arm was less than 5%. Marinus plans to submit an NDA for ganaxolone for the treatment of CDD to the FDA in mid-2021.
Satsuma Plunges on Disappointing Data on Migraine Treatment: Shares of clinical-stage biopharmaceutical company, Satsuma Pharmaceuticals, Inc. STSA plunged after it announced disappointing top-line results from its late-stage study of STS101 (dihydroergotamine [DHE] nasal) powder as an acute treatment for migraine. The phase III EMERGE efficacy study of STS101 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel-group study conducted in more than 1,140 migraine patients in the United States. After establishing full eligibility, EMERGE trial participants were randomized (1:1:1) to receive one of three treatments — STS101 DHE 3.9 mg, STS101 DHE 5.2 mg or a matching placebo — and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication.
The top-line data from the study did not show statistically significant differences between either dosage strengths of STS101 and placebo on co-primary endpoints of freedom from pain and most bothersome symptom at two hours post-administration. Further analysis of the data is ongoing and the company will provide a more detailed update on its business plans thereafter.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology index gained 5.22% in the last four trading sessions. Among the biotech giants, Alexion gained 6.74% during this period. Over the past six months, shares of Alexion have gained 52.96%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Submits BLA, ALBO Gains on Study Data & More)
What’s Next in Biotech?
Stay tuned for more pipeline updates.
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